TRANEXAMIC ACID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)

Available from:

Gland Pharma Limited

INN (International Name):

TRANEXAMIC ACID

Composition:

TRANEXAMIC ACID 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is contraindicated: • In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. • In patients with active intravascular clotting [see Warnings and Precautions (5.1)]. • In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions (5.4)]. Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that

Product summary:

Tranexamic Acid Injection, USP is a clear, colorless solution supplied as follows: NDC                                       Tranexamic Acid Injection, USP (100 mg/mL)         Package Factor 68083-160-10                          1,000 mg/10 mL Single-Dose Vial                             10 vials per carton Storage Conditions Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRANEXAMIC ACID - TRANEXAMIC ACID INJECTION, SOLUTION
GLAND PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRANEXAMIC ACID
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRANEXAMIC ACID
INJECTION.
TRANEXAMIC ACID INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1986
RECENT MAJOR CHANGES
Warnings and Precautions, Risk of Medication Errors Due to Incorrect
Route of Administration. (5.2)
12/2020
INDICATIONS AND USAGE
Tranexamic acid is an antifibrinolytic indicated in patients with
hemophilia for short-term use (2 to 8 days)
to reduce or prevent hemorrhage and reduce the need for replacement
therapy during and following tooth
extraction. (1)
DOSAGE AND ADMINISTRATION
• Before Extraction: Administer 10 mg/kg actual body weight of
tranexamic acid injection intravenously
with replacement therapy. (2.1)
• After Extraction: Administer 10 mg/kg actual body weight 3 to 4
times daily for 2 to 8 days. Infuse no
more than 1 mL/minute to avoid hypotension. (2.1)
• Reduce the dosage for patients with renal impairment. (2.2, 8.6)
DOSAGE FORMS AND STRENGTHS
• Injection: 1,000 mg tranexamic acid (100 mg/mL) in 10 mL
single-dose vials. (3)
CONTRAINDICATIONS
• In patients with subarachnoid hemorrhage, due to risk of cerebral
edema and cerebral infarction. (4)
• In patients with active intravascular clotting. (4)
• In patients with severe hypersensitivity reactions to tranexamic
acid or any of the ingredients. (4)
WARNINGS AND PRECAUTIONS
• Risk of Thrombosis with Concomitant Use of Factor IX: Avoid
concomitant use. (5.1)
• Risk of Medication Errors Due to Incorrect Route of
Administration: FOR INTRAVENOUS USE ONLY. (5.2)
• Seizures: Inadvertent injection into neuraxial system may result
in seizures. (5.3)
• Hypersensitivity Reactions: In case of severe reaction,
discontinue use and seek immediate medical
attention. (5.4)
• Visual Disturbances: Visual or ocular adverse effects may occur.
Discontinue